Evaluation of Automatic Class III Designation (De Novo) Summaries (K123250 letter added)
The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the de novo classification option as an alternate pathway to classify novel devices of low to moderate risk that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission. Section 513(f)(2) of the FD&C Act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), on July 9, 2012, to allow a sponsor to submit a de novo classification request to the FDA for novel low to moderate risk devices without first being required to submit a 510(k).
There are two options for de novo classification for novel devices of low to moderate risk.
- Option 1: Any person who receives an NSE determination in response to a 510(k) submission may, within 30 days of receipt of the NSE determination, submit a de novo request for the FDA to make a risk-based evaluation for classification of the device into Class I or II.
- Option 2: Any person who determines that there is no legally marketed device upon which to base a determination of substantial equivalence may submit a de novo request for the FDA to make a risk-based classification of the device into Class I or II, without first submitting a 510(k) and receiving an NSE determination.
Devices that are classified through the de novo process may be marketed and used as predicates for future 510(k) submissions.
Since 2010, the FDA has begun releasing summary documents for devices classified through the de novo process. The de novo summary is intended to present an objective and balanced summary of the scientific evidence that served as the basis for the decision to grant a de novo request. The de novo summary also serves as a resource regarding the types of information necessary to support substantial equivalence for device manufacturers that may wish to use the device as a predicate for future 510(k) submissions.
Links to all available de novo summary documents can be found in the table below.
|Device Name||510(k) Number||Approval Letter||Decision Summary|
|Infrascanner Model 1000||K080377||Approval Letter ||Decision Summary |
|Zeltiq™ Dermal Cooling Device||K080521||Approval Letter |
|Bio-Seal Lung Biopsy Tract Plug System||K082438||Approval Letter ||Decision Summary |
|Erchonia ML Scanner||K082609||Approval Letter |
|NuMED NuCLEUS and NuCLEUS-X BAV Catheters||K082776||Approval Letter ||Decision Summary |
|Hem-Avert Perianal Stabilizer||K083692||Approval Letter |
|ViruLite Cold Sore Machine||K083767||Approval Letter ||Decision Summary |
|RIDASCREEN Norovirus 3rd Generation EIA||K093295||Approval Letter |
|Prostate Mechanical Imager||K093579||Approval Letter ||Decision Summary |
|LipiFlow Thermal Pulsation System||K093937||Approval Letter ||Decision Summary |
|Steris Verify Spore Test Strip for S40||K100049||Approval Letter ||Decision Summary |
|InBios DENV Detect IgM Capture ELISA||K100534||Approval Letter ||Decision Summary |
|Cabochon System||K101231||Approval Letter ||Decision Summary |
|Widex C4-PA Wireless Air-Conduction Hearing Aid||K101699||Approval Letter ||Decision Summary |
|Aptus Endovascular Suturing System||K102333||Approval Letter ||Decision Summary |
|ImmunoCAP Tryptase||K103039||Approval Letter ||Decision Summary |
|Percutaneous Surgical Set with 5 mm or 10 mm Attachments||K110431||Approval Letter ||Decision Summary |
|STRATIFY JCV Antibody ELISA||K112394||Approval Letter ||Decision Summary |
|Neuropsychiatric EEG-Based Assessment Aid for ADHD (NEBA) System||K112711||Approval Letter ||Decision Summary |
|Proteus Personal Monitor Including Ingestion Event Marker||K113070||Approval Letter ||Decision Summary |
|PORTRAIT TOXIGENIC C. DIFFICILE ASSAY||K113358||Approval Letter ||Decision Summary |
|Verigene® Gram Positive Blood Culture Nucleic Acid Test (BC-GP)||K113450||Approval Letter ||Decision Summary |
|COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay||K121291||Approval Letter ||Decision Summary |
|xTAG® Gastrointestinal Pathogen Panel (GPP)||K121454||Approval Letter ||Decision Summary |
|Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS||K122282||Approval Letter ||Decision Summary |
|AXIOS Stent and Delivery System||K123250||Approval Letter |
|X-ray Attenuating Cream||K123422||Approval Letter ||Decision Summary |
|Vysis EGR1 FISH Probe Kit||K123951||Approval Letter ||Decision Summary |
|Illumina MiSeqDx Platform||K123989||Approval Letter ||Decision Summary |
|FerriScan R2-MRI Analysis System||K124065||Approval Letter ||Decision Summary |
|VITEK®MS||K124067||Approval Letter ||Decision Summary |
|NeoTract UroLift System, Model REF UL400||K130651||Approval Letter ||Decision Summary |
|Xpert MTB/RIF Assay||K131706||Approval Letter ||Decision Summary |
|MiSeqDx Universal Kit 1.0||K133136||Approval Letter ||Decision Summary |